Status:
COMPLETED
Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Lower Respiratory Tract Infection
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a 7.5% higher combin...
Detailed Description
Background: Acute lower respiratory tract infections (LRTI), i.e. acute bronchitis and acute exacerbations of chronic obstructive pulmonary disease (AECOPD), and community-acquired pneumonia (CAP), em...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older, admitted from the community or a nursing home with acute (i.e., at least 1 day but less than 28 days) LRTI as the main diagnosis consisting of having at least two of the following:
- new or increased respiratory signs or symptoms (i.e., cough, sputum production, dyspnea, auscultatory findings of abnormal breath sounds and rales, pleuritic chest pain) with or without inflammatory signs (core body temperature \> 38.0° C, leukocyte count \> 10 or \< 4 x 10\^9 cells L-1).
- CAP is defined by the presence of LRTI along with a new or increased infiltrate on chest radiograph. Severity scores of CAP (pneumonia severity index \[PSI\] and CURB-65) will be calculated.
- COPD is defined by post-bronchodilator spirometric criteria according to the GOLD-guidelines as a FEV1/FVC ratio below 70% and the severity categorized into mild (FEV1 \<= 80% of predicted), moderate (50% \>= FEV1 \< 80%), severe (30% \>= FEV1 \< 50%) and very severe (FEV1 \< 30%), respectively. Severity of acute exacerbations of COPD will be graded as proposed. Acute bronchitis is defined as LRTI in the absence of an underlying lung disease or focal chest signs and infiltrates on chest X-ray, respectively. Patients who are on admission judged as having an LRTI but have another final diagnosis, will be classified as "others".
- Ability to understand verbal and written instructions and informed consent.
Exclusion
- Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language) and no translation (e.g. family members) available.
- Patients with active intravenous drug use.
- Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 10\^9/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with present neutrophil count \< 500 x 10\^9/L and patients under chemotherapy with neutrophils 500-1000 x 10\^9/L with an expected decrease to values \< 500 x 10\^9/L); patients with cystic fibrosis, infection with M. tuberculosis, L. pneumophila, Listeria spp. hospital stay within 14 days of inclusion.
- Accompanying chronic (e.g. osteomyelitis), abscess (e.g. brain, pleural empyema) infection or endocarditis.
- Terminal and very severe medical co-morbidity where death is imminent or has to be expected in the current hospitalization (e.g. due to malignancy, cardiac, renal or hepatic failure, comfort therapy).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
1002 Patients enrolled
Trial Details
Trial ID
NCT00350987
Start Date
October 1 2006
End Date
June 1 2008
Last Update
September 23 2008
Active Locations (1)
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1
University Hospital in Basel
Basel, Canton of Basel-City, Switzerland, 4000